Catalog Number

00-1402-8116

Brand Name

6.5 and 7.3mm Large Fragment Cannulated Screw System

Version/Model Number

00-1402-8116

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K190324

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Public Device Record Key

97fa69b5-0377-407e-9126-0a7ba01d54fe

Public Version Date

June 01, 2021

Public Version Number

1

DI Record Publish Date

May 24, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-